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Vascular Changes Due to Different Treatments of Lymphedema Secondary to Postoperative Breast Cancer

3. august 2015 opdateret af: Elaine Caldeira de Oliveira Guirro, University of Sao Paulo
The objective of this study is to evaluate the effect of elastic compression, functional compressive bandaging (ECF) and active exercises in the bloodstream of the upper member ipsilateral to the surgical procedure for the treatment of breast cancer.

Studieoversigt

Status

Ukendt

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

With increasing survival of women treated for breast cancer, it becomes necessary to evaluate the effect of therapeutic resources in morbidity due to surgical treatment of breast cancer. The objective of this study is to evaluate the effect of elastic compression, functional compressive bandaging (ECF) and active exercises in the bloodstream of the upper member ipsilateral to the surgical procedure for the treatment of breast cancer. The study will be conducted according to design random cross over and wash out period of 7 days. They will be evaluated 30 volunteers aged between 45 and 70 years, submitted to treatment of breast cancer. The volunteers will be submitted to three different therapeutic procedures applied randomly by lot: active exercises, functional compressive bandaging with active exercises and elastic compression with active exercises. The profile of blood flow, including speed and direction, will be assessed by Doppler ultrasound before and after, at 0, 15, 30 minutes. Normality will be verified by the Shapiro-Wilk test, and the effect of behavior between pre- and post-intervention will be evaluated by ANOVA two-way followed by post-hoc test Friedman followed rank, p <0.05 . The data obtained in the study are intended to enhance the forms of physical therapy intervention in the face of circulatory morbidities resulting from breast cancer treatments.

Undersøgelsestype

Interventionel

Tilmelding (Forventet)

3

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

45 år til 60 år (Voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Kvinde

Beskrivelse

Inclusion Criteria:

  • women diagnosed with breast cancer undergoing surgical treatment combined with axillary dissection or sentinel node biopsy
  • diagnosed with moderate to severe unilateral lymphedema

Exclusion Criteria:

  • Women with muscle-tendon injury and / or joint damage in the -affected limb,
  • skin disorders,
  • diabetes,
  • circulatory disease not controlled, -chemotherapy
  • radiotherapy,
  • diagnostic with metastasis in the upper limb
  • women pregnancy.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Tildeling: Randomiseret
  • Interventionel model: Crossover opgave
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: therapeutic exercises
The applied therapeutic exercises involve shoulder movements including flexion, extension, abduction, adduction, internal and external rotation in isolated or combined movements, with ten repetitions of each movement, associated with the music, and stretching movements finalizing the sequence of movements.
Andet: therapeutic exercises
The applied therapeutic exercises involve shoulder movements including flexion, extension, abduction, adduction, internal and external rotation in isolated or combined movements, with ten repetitions of each movement, associated with the music, and stretching movements finalizing the sequence of movements.
Aktiv komparator: elastic compression
exercises for upper limb will be performed for an hour associated with the use of elastic compression. Elastic compression will be effected through a clamp brand compression of 30-40 mmHg according to the measures of voluntary member.
Andet: elastic compression
exercises for upper limb will be performed for an hour associated with the use of elastic compression. Elastic compression will be effected through a clamp brand compression of 30-40 mmHg according to the measures of voluntary member.
Aktiv komparator: functional compressive bandaging
exercises for upper limb will be performed for an hour associated with the use of functional compressive bandaging. The functional compressive bandaging will be held with the volunteer sitting with ipsilateral upper limb resting on the support surgery. After hydration member a cotton mesh is used to prevent friction density 1cm strip of foam on the member to be wrapped. Elastic bandages of cotton will be involved 5 cm, 10 cm, 15 cm from the fingers to the axillary region multilayered
Andet: functional compressive bandaging
exercises for upper limb will be performed for an hour associated with the use of functional compressive bandaging. The functional compressive bandaging will be held with the volunteer sitting with ipsilateral upper limb resting on the support surgery. After hydration member a cotton mesh is used to prevent friction density 1cm strip of foam on the member to be wrapped. Elastic bandages of cotton will be involved 5 cm, 10 cm, 15 cm from the fingers to the axillary region multilayered

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Doppler Ultrasound- velocity of blood flow
Tidsramme: one day
Doppler ultrasound is used to measure the velocity of blood flow of the axillary and brachial vein of the upper limb with lymphedema
one day

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

University of Sao Paulo

Efterforskere

  • Ledende efterforsker: Elaine Guirro, University of Sao Paulo- Ribeirao Preto- Brazil

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. august 2015

Primær færdiggørelse (Faktiske)

1. august 2015

Studieafslutning (Forventet)

1. juli 2016

Datoer for studieregistrering

Først indsendt

10. juni 2015

Først indsendt, der opfyldte QC-kriterier

3. august 2015

Først opslået (Skøn)

6. august 2015

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

6. august 2015

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

3. august 2015

Sidst verificeret

1. august 2015

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • HC-FMRP nº 810616/2014

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Brystkræft

Kliniske forsøg med therapeutic exercises

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Betingelser

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Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

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